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博茨瓦纳使用和未使用基于多替拉韦的抗逆转录病毒疗法的避孕植入剂使用者中的依托孕烯浓度。

Etonogestrel concentrations among contraceptive implant users in Botswana using and not using dolutegravir-based antiretroviral therapy.

机构信息

Columbia University Medical Center, 622 West 168th Street, New York, NY 10032, United States.

Botswana-University of Pennsylvania Partnership, University of Botswana Main Campus 244G - Room 103, Gaborone, Botswana; Botswana Harvard Partnership, Private Bag BO 320, Gaborone, Botswana.

出版信息

Contraception. 2020 Sep;102(3):174-179. doi: 10.1016/j.contraception.2020.04.019. Epub 2020 May 7.

Abstract

OBJECTIVES

To evaluate whether etonogestrel concentrations are reduced to a level that could potentially reduce contraceptive efficacy when the etonogestrel contraceptive implant is used concomitantly with dolutegravir-based antiretroviral therapy (ART).

STUDY DESIGN

We conducted a non-randomized, open-label, cross-sectional pharmacokinetic study among women using single-rod etonogestrel contraceptive implants in Botswana. We compared plasma etonogestrel concentrations, sampled at a single time-point between 3 and 12 months from implant insertion, among implant users living with HIV and receiving dolutegravir-based ART with HIV-negative implant users. We also assessed concentrations among implant users living with HIV and receiving efavirenz-based ART. We compared geometric mean etonogestrel concentrations analyzing data from 142 participants: 97 HIV-negative, 30 using dolutegravir, and 15 using efavirenz.

RESULTS

The groups were similar. Duration of implant use was between 3 and 12 months (median = 5). Geometric mean etonogestrel plasma concentrations and 90% confidence intervals of the mean were 227.5(212.4-243.8), 289.6(251.8-333.0) and 76.4(63.9-91.4) pg/mL among the HIV-negative, dolutegravir- and efavirenz-based ART groups, respectively. All women in the HIV-negative and dolutegravir-based ART groups had etonogestrel concentrations above 90 pg/mL; 9/15 women (60%) using efavirenz-based ART had concentrations below 90 pg/mL. On average, etonogestrel levels were lower among individuals who had implants inserted for longer durations.

CONCLUSIONS

Implant users receiving dolutegravir-based ART had a higher mean etonogestrel concentration compared to HIV-negative women, and none had etonogestrel concentrations below the posited threshold for ovulation suppression. In contrast, women in the efavirenz-group had much lower etonogestrel concentrations. Overall, these data provide evidence that the etonogestrel implant may be effectively combined with dolutegravir-based ART regimens.

IMPLICATIONS

The etonogestrel implant remains a highly effective contraceptive option for women living with HIV who use dolutegravir-based ART.

摘要

目的

评估当依托孕诺酮避孕植入物与基于多替拉韦的抗逆转录病毒疗法(ART)同时使用时,依托孕诺酮的浓度是否降低到可能降低避孕效果的水平。

研究设计

我们在博茨瓦纳开展了一项非随机、开放标签、横断面药代动力学研究,研究对象为使用单根依托孕诺酮避孕植入物的女性。我们比较了在植入物插入后 3 至 12 个月期间单点采集的血浆依托孕诺酮浓度,比较了接受基于多替拉韦的 ART 的 HIV 阳性植入物使用者与 HIV 阴性植入物使用者之间的浓度,也比较了接受基于依非韦伦的 ART 的 HIV 阳性植入物使用者之间的浓度。我们分析了 142 名参与者的数据,比较了几何平均依托孕诺酮浓度:97 名 HIV 阴性、30 名接受多替拉韦和 15 名接受依非韦伦。

结果

各组间无差异。植入物使用时间为 3 至 12 个月(中位数=5)。几何平均依托孕诺酮血浆浓度及其 90%置信区间分别为 HIV 阴性、多替拉韦和依非韦伦 ART 组的 227.5(212.4-243.8)、289.6(251.8-333.0)和 76.4(63.9-91.4)pg/ml。HIV 阴性和多替拉韦 ART 组的所有女性依托孕诺酮浓度均高于 90pg/ml;依非韦伦 ART 组的 15 名女性中有 9 名(60%)浓度低于 90pg/ml。平均而言,植入物使用时间较长的个体依托孕诺酮水平较低。

结论

与 HIV 阴性女性相比,接受多替拉韦为基础的 ART 的植入物使用者平均依托孕诺酮浓度更高,且无一人的依托孕诺酮浓度低于排卵抑制的假定阈值。相比之下,依非韦伦组的女性依托孕诺酮浓度要低得多。总体而言,这些数据提供了证据,表明依托孕诺酮植入物可能与多替拉韦为基础的 ART 方案有效结合。

意义

对于使用基于多替拉韦的 ART 的 HIV 阳性女性,依托孕诺酮避孕植入物仍然是一种高度有效的避孕选择。

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